Class II · ModerateActive recall
Glenmark Ranitidine Tablets USP 150 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A
Where it was soldNatiowide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Presence of NDMA impurity detected in product.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGlenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ foreign manufacturer
| Distributed by / for | Glenmark Pharmaceuticals Inc., USA Mahwah, NJ |
| NDC | 68462-248-60 |
Show the full FDA record
| Full product label | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | Natiowide |
| Quantity | 208,668 bottles |
| Recall initiated | 2019-12-17 |
| Report date | 2020-01-15 |
| Recall completed | — |
| Recall number | D-0639-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Mahwah NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.